Nevin Manimala

Trials. 2023 May 30;24(1):364. doi: 10.1186/s13063-022-06956-9.

ABSTRACT

INTRODUCTION: The BATCH trial is a multi-centre randomised controlled trial to compare procalcitonin-guided management of severe bacterial infection in children with current management. PRECISE is a mechanistic sub-study embedded into the BATCH trial. This paper describes the statistical analysis plan for the BATCH trial and PRECISE sub-study.

METHODS: The BATCH trial will assess the effectiveness of an additional procalcitonin test in children (aged 72 h to 18 years) hospitalised with suspected or confirmed bacterial infection to guide antimicrobial prescribing decisions. Participants will be enrolled in the trial from randomisation until day 28 follow-up. The co-primary outcomes are duration of intravenous antibiotic use and a composite safety outcome. Target sample size is 1942 patients, based on detecting a 1-day reduction in intravenous antibiotic use (90% power, two-sided) and on a non-inferiority margin of 5% risk difference in the composite safety outcome (90% power, one-sided), while allowing for up to 10% loss to follow-up.

RESULTS: Baseline characteristics will be summarised overall, by trial arm, and by whether patients were recruited before or after the pause in recruitment due to the COVID-19 pandemic. In the primary analysis, duration of intravenous antibiotic use will be tested for superiority using Cox regression, and the composite safety outcome will be tested for non-inferiority using logistic regression. The intervention will be judged successful if it reduces the duration of intravenous antibiotic use without compromising safety. Secondary analyses will include sensitivity analyses, pre-specified subgroup analyses, and analysis of secondary outcomes. Two sub-studies, including PRECISE, involve additional pre-specified subgroup analyses. All analyses will be adjusted for the balancing factors used in the randomisation, namely centre and patient age.

CONCLUSION: We describe the statistical analysis plan for the BATCH trial and PRECISE sub-study, including definitions of clinical outcomes, reporting guidelines, statistical principles, and analysis methods. The trial uses a design with co-primary superiority and non-inferiority endpoints. The analysis plan has been written prior to the completion of follow-up.

TRIAL REGISTRATION: BATCH: ISRCTN11369832, registered 20 September 2017, doi.org/10.1186/ISRCTN11369832.

PRECISE: ISRCTN14945050, registered 17 December 2020, doi.org/10.1186/ISRCTN14945050.

PMID:37254156 | DOI:10.1186/s13063-022-06956-9

J Health Popul Nutr. 2023 May 30;42(1):49. doi: 10.1186/s41043-023-00393-3.

ABSTRACT

BACKGROUND: Diabetes is a major global public health problem that requires self-management behavior. However, this is difficult to implement in practice and requires new approaches. The purpose of this study was to evaluate nutritional promotion interventions for dietary adherence and lessons learned to improve self-management.

METHODS: A quasi-experimental study was conducted from January 2020 to February 2021 in North Shoa Zone public hospital. The study enrolled 216 type II diabetic patients from four public hospitals. Study participants were randomly assigned to intervention and control groups at an individual level. Data were measured twice (baseline and end line survey after six months using interviewer-administered questionnaires). Data were entered into Epi Data V.3.1 and analyzed using SPSS version 22. Data were presented as means of standard deviations for continuous variables and percentages for categorical variables. Intervention and control groups were compared before and after intervention using independent t tests. A p-value less than 0.05 was considered significant for all statistical tests.

RESULTS: A total of 216 type II diabetics participated in this study. Nutritional promotion intervention programs increased adherence to the mean number of days adhering to a healthy diet (p < 0.0001). Specifically, the nutrition promotion program improved daily intake of fruits and vegetables, low glycemic index foods, high fiber foods, healthy fish oils, low sugar foods, and healthy eating plans (p ≤ 0.050). Mean fasting blood glucose levels were significantly decreased after the educational intervention (p ≤ 0.05).

CONCLUSION: This study demonstrates that a nutrition-promoting intervention can significantly change patients’ adherence to healthy eating behaviors and effectively improve their glycemic control. Health care providers should integrate programs that promote nutrition education into existing health systems service. Primary care platforms such as health posts and health centers can play a key role in integrating health promotion programs to improve self-management behaviors.

PMID:37254151 | DOI:10.1186/s41043-023-00393-3

Breast Cancer Res. 2023 May 30;25(1):61. doi: 10.1186/s13058-023-01650-3.

ABSTRACT

BACKGROUND: Multiparametric magnetic resonance imaging (MP-MRI) has high sensitivity for diagnosing breast cancers but cannot always be used as a routine diagnostic tool. The present study aimed to evaluate whether the diagnostic performance of perfluorobutane (PFB) contrast-enhanced ultrasound (CEUS) is similar to that of MP-MRI in breast cancer and whether combining the two methods would enhance diagnostic efficiency.

PATIENTS AND METHODS: This was a head-to-head, prospective, multicenter study. Patients with breast lesions diagnosed by US as Breast Imaging Reporting and Data System (BI-RADS) categories 3, 4, and 5 underwent both PFB-CEUS and MP-MRI scans. On-site operators and three reviewers categorized the BI-RADS of all lesions on two images. Logistic-bootstrap 1000-sample analysis and cross-validation were used to construct PFB-CEUS, MP-MRI, and hybrid (PFB-CEUS + MP-MRI) models to distinguish breast lesions.

RESULTS: In total, 179 women with 186 breast lesions were evaluated from 17 centers in China. The area under the receiver operating characteristic curve (AUC) for the PFB-CEUS model to diagnose breast cancer (0.89; 95% confidence interval [CI] 0.74, 0.97) was similar to that of the MP-MRI model (0.89; 95% CI 0.73, 0.97) (P = 0.85). The AUC of the hybrid model (0.92, 95% CI 0.77, 0.98) did not show a statistical advantage over the PFB-CEUS and MP-MRI models (P = 0.29 and 0.40, respectively). However, 90.3% false-positive and 66.7% false-negative results of PFB-CEUS radiologists and 90.5% false-positive and 42.8% false-negative results of MP-MRI radiologists could be corrected by the hybrid model. Three dynamic nomograms of PFB-CEUS, MP-MRI and hybrid models to diagnose breast cancer are freely available online.

CONCLUSIONS: PFB-CEUS can be used in the differential diagnosis of breast cancer with comparable performance to MP-MRI and with less time consumption. Using PFB-CEUS and MP-MRI as joint diagnostics could further strengthen the diagnostic ability. Trial registration Clinicaltrials.gov; NCT04657328. Registered 26 September 2020. IRB number 2020-300 was approved in Chinese PLA General Hospital. Every patient signed a written informed consent form in each center.

PMID:37254149 | DOI:10.1186/s13058-023-01650-3

BMC Public Health. 2023 May 30;23(1):1006. doi: 10.1186/s12889-023-15869-4.

ABSTRACT

BACKGROUND: The digitalization of healthcare requires users to have sufficient competence in using digital health technologies. In the Netherlands, as well as in other countries, there is a need for a comprehensive, person-centered assessment of eHealth literacy to understand and address eHealth literacy related needs, to improve equitable uptake and use of digital health technologies.

OBJECTIVE: We aimed to translate and culturally adapt the original eHealth Literacy Questionnaire (eHLQ) to Dutch and to collect initial validity evidence.

METHODS: The eHLQ was translated using a systematic approach with forward translation, an item intent matrix, back translation, and consensus meetings with the developer. A validity-driven and multi-study approach was used to collect validity evidence on 1) test content, 2) response processes and 3) internal structure. Cognitive interviews (n = 14) were held to assess test content and response processes (Study 1). A pre-final eHLQ version was completed by 1650 people participating in an eHealth study (Study 2). A seven-factor Confirmatory Factor Analysis (CFA) model was fitted to the data to assess the internal structure of the eHLQ. Invariance testing was performed across gender, age, education and current diagnosis.

RESULTS: Cognitive interviews showed some problems in wording, phrasing and resonance with individual’s world views. CFA demonstrated an equivalent internal structure to the hypothesized (original) eHLQ with acceptable fit indices. All items loaded substantially on their corresponding latent factors (range 0.51-0.81). The model was partially metric invariant across all subgroups. Comparison of scores between groups showed that people who were younger, higher educated and who had a current diagnosis generally scored higher across domains, however effect sizes were small. Data from both studies were triangulated, resulting in minor refinements to eight items and recommendations on use, score interpretation and reporting.

CONCLUSION: The Dutch version of the eHLQ showed strong properties for assessing eHealth literacy in the Dutch context. While ongoing collection of validity evidence is recommended, the evidence presented indicate that the eHLQ can be used by researchers, eHealth developers and policy makers to identify eHealth literacy needs and inform the development of eHealth interventions to ensure that people with limited digital access and skills are not left behind.

PMID:37254148 | DOI:10.1186/s12889-023-15869-4

BMC Public Health. 2023 May 30;23(1):1011. doi: 10.1186/s12889-023-15952-w.

ABSTRACT

BACKGROUND: A high fertility rate can have a number of expensive consequences for developing nations, such as limiting economic growth, adversely impacting women and their children’s health, and reducing access to quality education, nutrition, and employment. The problem is more obvious in Ethipia’s high fertility regions. Therefore, this study aimed to assess predictors of desire to limit childbearing among reproductive age women in high fertility regions in Ethiopia.

METHODS: The analysis was based on secondary data using the 2016 Ethiopian Demographic and Health Survey. Stata version 14 software was used for analysis. A multi-level mixed-effect logistic regression analysis was fitted. Adjusted Odds Ratio at 95% confidence interval was used to show the strength and direction of the association. Statistical significance was declared at a P- value less than 0.05.

RESULTS: The overall desire to limit childbearing in high fertility regions in Ethiopia was 37.7% (95% CI: 36.28, 39.17). Age; 25-34 (AOR = 3.74; 95% CI: 2.97, 4.73), 35-49 years (AOR = 14; 95% CI: 10.85, 18.06), women education; Primary education (AOR = 0.73; 95% CI: 0.61, 0.88), secondary and higher (AOR = 0.29; 95% CI: 0.19, 0.43), from the community level variables Oromia National Regional state (AOR = 5.86; 95% CI: 2.82, 12.23), high proportion of community level poverity (AOR = 0.67; 95% CI: 0.45, 0.98), and high proportion of community level media exposure (AOR = 1.53; 95% CI: 1.07, 2.19) were statistically significant factors for desire to limit childbearing in high fertility regions of Ethiopia.

CONCLUSION: Nearly four in ten women had the desire to limit childbearing in high fertility regions in Ethiopia. Thus, to fulfill the women’s desire to limit childbearing, Ministry of Health and health facilities are needed to increase financial support strategies and Family planning programs that enable pregnant women from poor households to use health services. In addition, increasing community level media exposure are important interventions.

PMID:37254145 | DOI:10.1186/s12889-023-15952-w

BMC Public Health. 2023 May 30;23(1):1007. doi: 10.1186/s12889-023-15988-y.

ABSTRACT

BACKGROUND: Over the past years, Mozambique has implemented several initiatives to ensure equitable coverage to health care services. While there have been some achievements in health care coverage at the population level, the effects of these initiatives on social inequalities have not been analysed.

OBJECTIVE: The present study aimed to assess changes in socioeconomic and geographical inequalities (education, wealth, region, place of residence) in health care coverage between 2015 and 2018 in Mozambique.

METHODS: The study was based on repeated cross-sectional surveys from nationally representative samples: the Survey of Indicators on Immunisation, Malaria and HIV/AIDS in Mozambique (IMASIDA) 2015 and the 2018 Malaria Indicator survey. Data from women of reproductive age (15 to 49 years) were analysed to evaluate health care coverage of three indicators: insecticide-treated net use, fever treatment of children, and use of Fansidar malaria prophylaxis for pregnant women. Absolute risk differences and the slope index of inequality (SII) were calculated for the 2015 survey period and the 2018 survey period, respectively. An interaction term between the socioeconomic and geographical variables and the period was included to assess inequality changes between 2015 and 2018.

RESULTS: The non-use of insecticide-treated nets dropped, whereas the proportion of women with children who were not treated for fever and the prevalence of women who did not take the full Fansidar dose during pregnancy decreased between 2015 and 2018. Significant reductions in the inequality related to insecticide-treated net use were observed for all socioeconomic variables. Concerning fever treatment, some reductions in socioeconomic inequalities were observed, though not statistically significant. For malaria prophylaxis, the SII was significant for education, wealth, and residence in both periods, but no significant inequality reductions were observed in any of these variables over time.

CONCLUSIONS: We observed significant reductions of socioeconomic inequalities in insecticide-treated net use, but not in fever treatment of children and Fansidar prophylaxis for pregnant women. Decision-makers should target underserved populations, specifically the non-educated, poor, and rural women, to address inequalities in health care coverage.

PMID:37254141 | DOI:10.1186/s12889-023-15988-y

BMC Med Educ. 2023 May 30;23(1):394. doi: 10.1186/s12909-023-04383-1.

ABSTRACT

There are many parameters that could be used to evaluate the quality of scientific meetings such as publication rates of meeting abstracts as full-text articles after the meeting or scoring with validated quality scales/tools that evaluate individual papers, project proposals, or submitted abstracts. This study aimed to determine the full-text publication rates for abstracts presented at Turkish National Medical Education Congresses and Symposia and to assess the quality of given abstracts. Abstracts presented at national medical education congresses and symposia between 2010 and 2014 in Türkiye were evaluated. Initially, the abstracts were evaluated if they were published as full-text articles in international and national peer-reviewed journals following the meeting. Secondly, the quality of presented abstracts was assessed with the Medical Education Research Study Quality Instrument (MERSQI) scale. Overall publication rate for the abstracts was 11.3%. The publication rate of oral and poster presentations were 26.6% and 8.1%, respectively. Oral presentations had a statistically higher publication rate than poster presentations (p = .000). The mean MERSQI score for abstracts was 7.73 ± 2.59. The oral presentations had higher MERSQI mean scores than poster presentations (8.28 ± 2.46 vs. 7.61 ± 2.6; p = .032). Similarly, published abstracts had a significantly higher score compared to unpublished abstracts (10.07 ± 2.74 vs. 7.43 ± 2.41; p = .000). Interestingly, there was no statistical difference between the mean MERSQI scores of the published oral and poster presentations (9.33 ± 2.45 vs. 10.61 ± 2.72; p = .101). This study showed that the main factor for a meeting abstract to be published as a full-text article is the scientific quality of the study. The quality of presentations at annual medical education meetings in Türkiye were low compared with international meetings which did not improve over five years. An institutional policy that would set quality standards for medical education research and increase the awareness of researchers on the topic might help improve the design, execution, and reporting of such studies in Türkiye. The MERSQI could be a valuable tool to monitor the quality of submitted abstracts and to increase the awareness of novice researchers on high quality research.

PMID:37254136 | DOI:10.1186/s12909-023-04383-1

Parasit Vectors. 2023 May 30;16(1):172. doi: 10.1186/s13071-023-05797-y.

ABSTRACT

BACKGROUND: Sarcoptic mange is one of the main parasitic diseases affecting the Iberian ibex Capra pyrenaica. Scabietic animals suffer a decline in body condition and reproductive fitness and in severe cases may die. Although several previous studies of the pathology of this disease and the physiological changes it produces in ibex have been carried out in recent years, our knowledge of the relationship between Sarcoptes scabiei and other ectoparasites of this host is still limited.

METHODS: We analysed 430 Iberian ibex skin samples. Ectoparasites were removed, counted and identified. Mite (S. scabiei) numbers were obtained after digesting the skin samples in a 5% KOH solution. We modelled mite numbers in terms of host sex and age, site, year, season and the presence of other ectoparasites such as ticks and lice using generalized linear mixed models (GLMMs) and ectoparasite co-occurrence patterns using two different models: the probabilistic model species co-occurrence and the generalized linear latent variable model (GLLVM).

RESULTS: The ectoparasite community was mainly composed of S. scabiei, six ticks (Haemaphysalis sulcata, Haemaphysalis punctata, Rhipicephalus bursa, Rhipicephalus turanicus, Dermacentor marginatus and Ixodes ricinus) and two lice (Bovicola crassipes and Linognathus stenopsis). Adult male ibex harboured more mites than females. Mite numbers varied greatly spatially and seasonally and increased with the presence of other parasites. Some positive co-occurrence relationships between pairs of different ectoparasites were observed, particularly between ticks. The presence of S. scabiei negatively affected lice and H. sulcata numbers.

CONCLUSIONS: Sarcoptic mange has spread above all in ibex populations in and around the Mediterranean Basin, where it is now found in almost a third of its host’s range. Mite numbers varied seasonally and spatially and were higher in male hosts. The presence of S. scabiei had a negative effect on lice numbers but favoured the presence of ticks.

PMID:37254132 | DOI:10.1186/s13071-023-05797-y

BMC Public Health. 2023 May 30;23(1):1016. doi: 10.1186/s12889-023-15799-1.

ABSTRACT

BACKGROUND: The COVID-19 pandemic as a public health crisis has led to a significant increase in mental health difficulties. Smoking is strongly associated with mental health conditions, which is why the pandemic might have influenced the otherwise decline in smoking rates. Persons belonging to socioeconomically disadvantaged groups may be particularly affected, both because the pandemic has exacerbated existing social inequalities and because this group was more likely to smoke before the pandemic. We examined smoking prevalence in a French cohort study, focusing on differences between educational attainment. In addition, we examined the association between interpersonal changes in tobacco consumption and educational level from 2018 to 2021.

METHODS: Using four assessments of smoking status available from 2009 to 2021, we estimated smoking prevalence over time, stratified by highest educational level in the TEMPO cohort and the difference was tested using chi² test. We studied the association between interpersonal change in smoking status between 2018 and 2021 and educational attainment among 148 smokers, using multinomial logistic regression.

RESULTS: Smoking prevalence was higher among those with low education. The difference between the two groups increased from 2020 to 2021 (4.8-9.4%, p < 0.001). Smokers with high educational level were more likely to decrease their tobacco consumption from 2018 to 2021 compared to low educated smokers (aOR = 2.72 [1.26;5.89]).

CONCLUSION: Current findings showed a widening of the social inequality gap in relation to smoking rates, underscoring the increased vulnerability of persons with low educational level to smoking and the likely inadequate focus on social inequalities in relation to tobacco control policies during the pandemic.

PMID:37254131 | DOI:10.1186/s12889-023-15799-1

BMC Psychiatry. 2023 May 30;23(1):377. doi: 10.1186/s12888-023-04752-6.

ABSTRACT

BACKGROUND: There are considerable differences among mental healthcare services, and especially in developed countries there are a substantial number of different services available. The intensity of mental healthcare has been an important variable in research studies (e.g. cohort studies or randomized controlled trials), yet it is difficult to measure or quantify, in part due to the fact that the intensity of mental healthcare results from a combination of several factors of a mental health service. In this article we describe the development of an instrument to measure the intensity of mental healthcare that is easy and fast to use in repeated measurements.

METHODS: The Mental Healthcare Intensity Scale was developed in four stages. First, categories of care were formulated by using focus group interviews. Second, the fit among the categories was improved, and the results were discussed with a sample of the focus group participants. Third, the categories of care were ranked using the Segmented String Relative Rankings algorithm. Finally, the Mental Healthcare Intensity Scale was validated as a coherent classification instrument.

RESULTS: 15 categories of care were formulated and were ranked on each of 12 different intensities of care. The Mental Healthcare Intensity Scale is a versatile questionnaire that takes 2-to-3 min to complete and yields a single variable that can be used in statistical analysis.

CONCLUSIONS: The Mental Healthcare Intensity Scale is an instrument that can potentially be used in cohort studies and trials to measure the intensity of mental healthcare as a predictor of outcome. Further study into the psychometric characteristics of the Mental Healthcare Intensity Scale is needed.

PMID:37254123 | DOI:10.1186/s12888-023-04752-6